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Abstract Number: 362

14-3-3η Early RA Biomarkers: Does Seronegative RA Exist?

Dirkjan van Schaardenburg1, Walter P. Maksymowych2, Maarten Boers3, Samina Turk4, Mairead Murphy5 and Anthony Marotta6, 1Dr Jan van Breemenstraat 2, Reade, Amsterdam, Netherlands, 2Department of Medicine, University of Alberta, Edmonton, AB, Canada, 3Deapartment of Epidemiology and Biostatistics, Jan van Breemen Research Institute/Reade, Amsterdam, Netherlands, 4Reade, Amsterdam, Netherlands, 5Augurex Life Sciences Corp., North Vancouver, BC, Canada, 61423 Dempsey Road, Augurex Life Sciences Corp., North Vancouver, BC, Canada

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ACPA, autoantibodies and diagnosis, Early Rheumatoid Arthritis, Rheumatoid Factor

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Session Information

Session Title: Rheumatoid Arthritis - Clinical Aspects: Novel Biomarkers and Other Measurements of Disease Activity

Session Type: Abstract Submissions (ACR)

Background/Purpose

RF and ACPA are used for early diagnosis and in prediction models for the risk of RA development in arthralgia patients. There remains a high unmet need for biomarkers in the earliest stages of RA to assist with detection and prognosis to enable therapy initiation within the first 6-12 weeks of symptom onset. The 14-3-3η serum protein and its corresponding anti-14-3-3η auto-antibodies are early complementary markers to RF/ACPA. This study describes their expression and diagnostic utility as well as their complementarity to RF/ACPA in early RA.

Methods

14-3-3η plasma protein levels were measured on the Augurex ELISA and 14-3-3η auto-antibody levels on the Meso-Scale-Discovery electro-chemiluminescent platform in 409 consecutive early RA patients (Reade cohort) according to the 2010 ACR/EULAR RA classification criteria.  Patients were DMARD-naïve, had a rheumatologist-confirmed diagnosis, median symptom duration was 4 months, mean age was 54 years and 73% were female. For 14-3-3η auto-antibody level determination, a composite score of six (6) peptides was generated. Peptides were selected based on their individual highest sensitivity for 100% specificity and their complementarity to maximize patient capture. An auto-antibody score of ≥380 U/ml was determined to be the best positive cut-off. Serum 14-3-3η protein levels were previously determined in these subjects with a positive diagnostic cut-off of > 0.19 ng/ml. Positive baseline status for each of the 14-3-3η markers and RF and ACPA were compared to examine the extent of early RA patient capture rate versus RF/ACPA.

Results

In the 409 patients, 67% (n=275) were positive for the 14-3-3η protein with median (IQR) titres of 0.63 (0.10-5.13) ng/ml and 77% (n=313) were positive for 14-3-3η auto-antibodies with median (IQR) values of 527 (387-753) U/ml. RF and ACPA positive rates in this cohort were 63% (n=259) and 69% (n=282), respectively. 76% (n=310) of patients were positive for one or both of RF and ACPA, 93% (n=394) were positive for either of the 14-3-3η markers and 96% for any one of the four markers. This represents 23% more patients identified by 14-3-3η markers alone compared to RF/ACPA, and 27% more when the four markers are used together. 

Conclusion

14-3-3η markers identify 93% of early RA patients compared to RF/ACPA alone at 76%. The combination of all four markers captures 96% of early RA patients which creates the opportunity to treat more patients within the therapeutic window and improve clinical outcomes.


Disclosure:

D. van Schaardenburg,

Augurex Life Sciences Corp,

5;

W. P. Maksymowych,

Augurex Life Sciences Corp,

5;

M. Boers,

Augurex Life Sciences Corp,

5;

S. Turk,
None;

M. Murphy,

Augurex Life Sciences Corp,

3;

A. Marotta,

Augurex Life Sciences Corp.,

3.

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